MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE; LUMINAL DEVICE FLUSHING TUBING SET, REUSABLE

Model Number	MAJ-2138
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was confirmed.One of the gray clips was missing on the orange connector and not returned for evaluation.The pin inside the orange connector had no signs of damage or corrosion.The two metal connectors on the other end of the connecting tube had signs of minor scratches on the housing.There were no punctures, residue or corrosion identified inside the tubing.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that the tabs on the connecting tube had broken off.There was no patient harm associated with the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information provided by the customer: b5/event description: the issue occurred during reprocessing, there was no procedural delay due to the issue, and the procedure was completed with the same set of equipment.
Event or Problem Description
The issue occurred during reprocessing, there was no procedural delay due to the issue, and the procedure was completed with the same set of equipment.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the manufacturing date could not be determined, however, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause could not be determined, however, it is possible that external load was applied to the cleaning tube, causing the lock lever to come off and make connection impossible.An external load on the irrigation tube may be caused by applying a force in the wrong direction.The event can be detected by following the instructions for use which state: ¿9 preparation and inspection 2 move the lock levers of the reprocessor side connector to make sure that they function properly and are not broken¿.Olympus will continue to monitor field performance for this device.

• Brand Name: CONNECTING TUBE
• Common Device Name: LUMINAL DEVICE FLUSHING TUBING SET, REUSABLE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16122320
• Report Number: 9610595-2023-00418
• Device Sequence Number: 15592917
• Product Code: FEB
• UDI-Device Identifier: 04953170404184
• UDI-Public: 04953170404184
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K190969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-2138
• Device Lot Number: 0XA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 01/23/2023; 03/07/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/13/2023; 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown